- The Indian government reportedly told the U.S.-India Business Council (USIBC) that it will not issue compulsory drug licenses to local firms for commercial purposes, according to Reuters. The licenses allow Indian firms to manufacture copies of patented drugs in order to help patients afford the products.
- The United States Trade Representative (USTR) has previously placed India on its "priority watch list" for its domestic intellectual patent rights laws. India's promise was included in recommendations USIBC submitted to USTR as the trade agency prepares to issue its 2016 report, which covers trade barriers more generally.
- Although India issued such a license in 2012 for a cancer drug made by Bayer, its patent office recently rejected an application from Lee Pharma. Lee Pharma had requested a compulsory license for a diabetes med made by AstraZeneca.
Neither the Indian government or the USTR has made any public statement on the issue. Although the World Trade Organization agreement gives countries the right to issue a compulsory license, the U.S. has pressured India to tighten its patent protection and copyright laws.
While US concerns in India extend broadly to cover copyright, piracy, trade secrets, the USTR's 2015 report specifically flagged the pharmaceutical market: "With respect to patents, the United States continues to have serious concerns about the innovation climate for the biopharmaceutical and other sectors."
Regarding compulsory licensing, the USTR is worried actions by India might specifically favor local firms over international companies.
While conditions such as a public health emergency could warrant a compulsory license, the US pharmaceutical industry believes India's legal interpretation allows a license to be granted merely because the drug in question isn't manufactured domestically.
In its submission to USTR last year, the Pharmaceutical Research and Manufacturers of America argued compulsory licensing should only be used as a last resort.
"Unfortunately, some countries appear to be using CLs to promote the local production of medicines at the expense of manufacturers and jobs in the United States and elsewhere. In 2013, for example, India’s Intellectual Property Appellate Board affirmed a CL for a patented oncology medicine, based in part on a finding that the patented medicine was not being manufactured in India," the trade association said.